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SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.

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ClinicalTrials.gov Identifier: NCT02036645
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.

Condition or disease Intervention/treatment Phase
Mild-Moderate Alzheimer's Disease Healthy Elderly Biological: MEDI1814 for IV injection Biological: MEDI1814 for Subcutaneous Injection Biological: IV Placebo Biological: Placebo for Subcutaneous Injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1814 in Subjects With Mild to Moderate Alzheimer's Disease.
Actual Study Start Date : February 4, 2014
Actual Primary Completion Date : September 15, 2016
Actual Study Completion Date : September 15, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEDI1814 IV
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Biological: MEDI1814 for IV injection
Monoclonal antibody for IV Injection

Placebo Comparator: IV Placebo
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Biological: MEDI1814 for IV injection
Monoclonal antibody for IV Injection

Biological: IV Placebo
Placebo for IV injection

Experimental: MEDI1814 Sub Cutaneous Injection
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Biological: MEDI1814 for Subcutaneous Injection
Monoclonal antibody for subcutaneous injection

Placebo Comparator: Subcutaneous Placebo
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Biological: Placebo for Subcutaneous Injection
Subcutaneous Placebo Injection




Primary Outcome Measures :
  1. Tolerability as Measured by Participant Withdrawal for an Adverse Event [ Time Frame: 4 months SAD; 7 months MAD ]
    Tolerability measured by participant withdrawal for an adverse event from randomization through end of study


Secondary Outcome Measures :
  1. Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57) [ Time Frame: 1 month ]
    Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)

  2. Maximum Plasma Concentration (Cmax) of Medi1814 [ Time Frame: 1 month ]
    Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)

  3. Mean Termination Half Life (t 1/2) of Medi1814 [ Time Frame: 1 month ]
    Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)

  4. Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed) [ Time Frame: Day 29 in SAD; Day 85 in MAD ]
    Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline

  5. Biomarker: Total Amyloid-beta 1-42 in Plasma [ Time Frame: Day 29 in SAD; Day 85 in MAD ]
    Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline

  6. Medi1814 Concentration in CSF Samples [ Time Frame: SAD Day 29; MAD Day 85 ]
    Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification

  7. Immunogenicity: Anti-drug Antibody Titer [ Time Frame: 4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests) ]
    Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease

Exclusion Criteria History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036645


Locations
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United States, California
Research Site
Glendale, California, United States, 91206
Research Site
Long Beach, California, United States, 90806
Research Site
Panorama City, California, United States, 91402
United States, Florida
Research Site
Hallandale Beach, Florida, United States, 33009
Research Site
Hialeah, Florida, United States, 33012
Research Site
Miami, Florida, United States, 33165
Research Site
Orlando, Florida, United States, 32806
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21225
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73112
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Thor Ostenfeld, MD AstraZeneca
Principal Investigator: David Han, MD Glendale Parexel Early Phase Clinical Unit

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02036645     History of Changes
Other Study ID Numbers: D4750C00001
First Posted: January 15, 2014    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs